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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028829
Receipt No. R000032967
Scientific Title The development of a standard method for participatory improvement of the workplace environment at small-sized enterprises: randomized controlled trial
Date of disclosure of the study information 2017/08/25
Last modified on 2019/02/25

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Basic information
Public title The development of a standard method for participatory improvement of the workplace environment at small-sized enterprises: randomized controlled trial
Acronym The development of a standard method for participatory improvement of the workplace environment at small-sized enterprises: randomized controlled trial
Scientific Title The development of a standard method for participatory improvement of the workplace environment at small-sized enterprises: randomized controlled trial
Scientific Title:Acronym The development of a standard method for participatory improvement of the workplace environment at small-sized enterprises: randomized controlled trial
Region
Japan

Condition
Condition depressive symptoms
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to conduct a workplace environment improvement program for small-sized enterprises and evaluate their effectiveness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes of indicator related to psychosomatic stress reaction at 3 months after the start of intervention.
Key secondary outcomes Changes of indicator related to job stressor and psychosocial support at 3 months after the start of intervention.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group: implement the workplace environment improvement program for 3 months.
Interventions/Control_2 Control group: after completing the workplace environment improvement program of the intervention group, implement the same intervention program.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Workers working at small-sized enterprises
2. Study participants with consent
Key exclusion criteria 1. Study participants without consent
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisanori Hiro
Organization University of Occupational and Environmental Health, Japan
Division name Department of Mental Health, Institute of Industrial Ecological Sciences
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Japan
TEL 093-691-7475
Email hiro@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayako Hino
Organization University of Occupational and Environmental Health, Japan
Division name Department of Mental Health, Institute of Industrial Ecological Sciences
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Japan
TEL 093-691-7475
Homepage URL
Email ayako-hino@med.uoeh-u.ac.jp

Sponsor
Institute Department of Mental Health, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization General incorporated foundation (Anshin Zaidan)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 07 Day
Last follow-up date
2017 Year 10 Month 20 Day
Date of closure to data entry
2017 Year 10 Month 31 Day
Date trial data considered complete
2017 Year 10 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 25 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032967

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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